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Outline I. New Drug Review Process: First Principles II. FDA Model of Serial Evaluation:Investigational New Drug (IND) .... Pre-Clinical studies .... Clinical Trials Phases I ? IV New Drug Application (NDA)Post-Marketing Surveillance III. Life Science Reviewers: Roles/Opportunities Pharmacology Physiology Toxicology PathologyMolecular Biology Chemistry Statistical ScienceVeterinary Med9447

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pre-clinical and clinical regulatory overview


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